FDA 483 - IndeCon, Inc. - December 12, 2024

An FDA inspection of IndeCon, Inc. in Dallas, TX, an HCT/P distributor, revealed significant deficiencies in record-keeping and storage temperature monitoring. The firm failed to maintain records concurrently, document incoming product evaluations, record HCT/P storage temperatures, and retain all required records for the specified duration. These issues indicate a lack of adequate control over critical processes for human cells, tissues, and cellular and tissue-based products.